MOST EMPOWER: Optimizing An Emotion Regulation Intervention
Status
Completed
Conditions
Cancer
Treatments
Behavioral: EMPOWER
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
This purpose of this study is to test a digital health intervention that may promote well-being among young adult cancer survivors. Investigators hope to learn more about wellness and health-related quality of life among young adult cancer survivors by promoting well-being and teaching skills for healthy coping and mood management.
Full description
The EMPOWER Intervention is composed of five components:
- Noting daily positive event, capitalizing on and savoring positive events, and gratitude.
- Mindfulness
- Positive Reappraisal
- Focusing on personal strengths, setting and working toward attainable goals
- Small of Kindness
For subjects who do not receive EMPOWER components or only receive some of the EMPOWER components, they will be given inert content. The inert content will cover Cognitive changes during Cancer, Diet, Weight Management, Financial Literacy and Sun Protection. The trial is a composed of a full factorial design with 32 (2X2X2X2X2) experimental conditions. Adolescents and Young Adults will receive 0, 1,2,3,4 or 5 Empower components.
Primary Objective
• Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to positive affect among post-treatment adolescent and young adult cancer survivors.
Secondary Objective
- Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to depression and anxiety among post-treatment adolescent and young adult cancer survivors.
- Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to life satisfaction and general self-efficacy among post-treatment adolescent and young adult cancer survivors.
Exploratory Objectives
- Summarize adherence and retention by participants over the course of the EMPOWER intervention.
- Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to physical functioning, fatigue, satisfaction with social roles and responsibilities.
- Identify which of five components in the EMPOWER web based curriculum, contribute meaningfully to health behaviors (diet, exercise, sedentary behavior, alcohol consumption, cigarette smoking).
- Examine the trajectory of change in positive affect, life satisfaction, general self-efficacy, depression, and anxiety among post-treatment adolescent and young adult cancer survivors post intervention by intervention component.
- Examine coping self-efficacy as a mediator of the relationship between EMPOWER intervention components and positive affect, life satisfaction, depression, and anxiety.
- Examine potential moderators (age, gender, social support, general self-efficacy, stressors, and positive events) of the relationship between EMPOWER intervention components and positive affect, life satisfaction, depression, and anxiety.
Enrollment
352 patients
Sex
All
Ages
15 to 39 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Able to read and understand English
- Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
- 15 to 39 years of age at diagnosis of first cancer and currently between the ages of 15 to 39
- Within 0-5 year's post-active treatment for initial diagnosis or recurrence (Note: Maintenance therapy for hematologic or hormonal therapy for breast cancers are not considered "active treatments" for purposes of this study).
- Internet access through a home computer, tablet or smartphone.
Exclusion criteria
- Ever been hospitalized for a psychiatric illness
- Currently receiving palliative or hospice care
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
None (Open label)
352 participants in 32 patient groups
Condition 1
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 2
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 3
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 4
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 5
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 6
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 7
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 8
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 9
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 10
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 11
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 12
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 13
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 14
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 15
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 16
Experimental group
Description:
1) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 17
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 18
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 19
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 20
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 21
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 22
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 23
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 24
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 25
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 26
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 27
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 28
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 29
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 30
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Condition 31
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection
Treatment:
Behavioral: EMPOWER
Condition 32
Experimental group
Description:
1) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness
Treatment:
Behavioral: EMPOWER
Trial contacts and locations
3
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Central trial contact
Vivian McAllister, BS
Data sourced from clinicaltrials.gov
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